All studies
RecruitingNAINTERVENTIONAL

Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis

This study aims to find the best way to treat a serious tummy infection called peritonitis, which can happen when small pouches in your bowel (diverticula) burst. Doctors will compare two surgical methods: one involves removing part of the bowel and rejoining it straight away, and the other involves doing the same but also creating a temporary opening in the tummy (a stoma) to divert waste while the rejoined bowel heals. Patients will be randomly assigned to one of these groups. The study wants to see which method leads to fewer problems and better recovery for patients. Everyone involved will have follow-up appointments to check their health and quality of life.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University Hospital, Rouen
Enrolment target
204
Start
11 Jun 2021
Estimated completion
01 Dec 2026

What is this study about?

This study is looking into the best way to treat a very serious tummy infection called peritonitis. This infection can happen when small pouches in the wall of your bowel, known as diverticula, become inflamed and burst, leaking bowel contents into your tummy. This is a medical emergency requiring surgery.

Doctors are comparing two different ways to do this surgery. In both methods, the damaged part of the bowel is removed, and the remaining healthy ends are stitched or stapled back together. The difference is that one group of patients will also have a temporary stoma created. A stoma is a small opening made on the outside of your tummy, connected to your bowel, which allows waste to be collected in a bag while the rejoined part of your bowel heals. This temporary stoma would be closed in another operation a few months later. The other group will have the bowel rejoined directly without a stoma.

The aim of this study is to see which of these two approaches leads to fewer problems after surgery and helps patients recover better. By comparing these two common methods, doctors hope to find clearer answers about which surgical strategy is generally safer and more effective for people with this serious condition.

Key takeaways

  • Compares two surgical ways to treat a serious tummy infection from a burst bowel pouch.
  • One method uses a temporary stoma, the other does not.
  • Patients are randomly assigned to a treatment group.
  • Involves follow-up visits up to 12 months.
  • Aims to find out which surgery is safer and more effective.

Who may be eligible?

To join this study, you must be at least 18 years old and have a severe tummy infection (peritonitis) caused by a burst pouch in your left bowel, which requires surgery where the bowel is reconnected. You need to be able to understand the study and agree to take part, or if you're too unwell, a family member or representative can give consent, which you'd then confirm later.

There are also reasons why you might not be able to join. For example, if you are extremely unwell from the infection (like being in septic shock), taking high doses of steroid medication, have had radiation treatment to your pelvis before, or have a weakened immune system. You also can't take part if you have a progressive cancer, a very high anaesthesia risk, or if the burst pouch is in the right side of your bowel. Pregnant or breastfeeding women, or those planning a pregnancy during the study, also cannot participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years or older?
  2. Do you have a severe tummy infection from a burst bowel pouch on your left side?
  3. Are you able to agree to take part in the study?
  4. Are you not currently pregnant or breastfeeding?
  5. Are you not taking high doses of steroids or have a severely weakened immune system?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to one of two surgical groups right before your operation. This is similar to flipping a coin and means neither you nor your doctor chooses which group you're in. Either you'll have surgery to remove the infected bowel and reconnect it, or you'll have the same surgery but also with a temporary stoma (a diversion for your bowel) created.

If you have a stoma, you'll need another operation at least three months later to close it. Before this second operation, you'll have a special X-ray test using a liquid dye to check that your bowel has healed properly. After your initial surgery and any stoma closure, you'll have follow-up visits with the hospital team at 6, 12, and 24 weeks. There will be a final check-up 12 months after your first surgery to see how you are doing, check for any ongoing issues, and understand how your quality of life has been affected.

Potential risks and benefits

This study is designed to help doctors understand the best surgical approach for a serious condition you already have. While there are no guarantees, potential benefits could include receiving a treatment that has been carefully compared to another, helping improve future care for patients. All surgeries carry risks, such as infection, bleeding, or complications from anaesthesia. There are also specific risks depending on whether you have a stoma or not, and possible complications related to stoma reversal. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (20)

  • CHR Beauvais
    Verified postcode
    Beauvais, France· Not yet recruiting
  • CHU Amiens
    Verified postcode
    Amiens, France· Recruiting
  • CH Beauvais
    Verified postcode
    Beauvais, France· Not yet recruiting
  • CHU Besançon
    Verified postcode
    Besançon, France· Not yet recruiting
  • APHP Avicenne
    Verified postcode
    Bobigny, France· Not yet recruiting
  • CHU Brest
    Verified postcode
    Brest, France· Recruiting
  • CHU Caen
    Verified postcode
    Caen, France· Not yet recruiting
  • CHU Clermont Ferrand
    Verified postcode
    Clermont-Ferrand, France· Not yet recruiting
  • APHP Henri Mondor
    Verified postcode
    Créteil, France· Not yet recruiting
  • CHU Grenoble
    Verified postcode
    Grenoble, France· Not yet recruiting
  • CHU Limoges
    Verified postcode
    Limoges, France· Not yet recruiting
  • CHU Lyon
    Verified postcode
    Lyon, France· Not yet recruiting

Common questions

What is peritonitis?

Peritonitis is a very serious infection of the lining of your tummy, usually caused by something bursting inside, like part of your bowel.

What is a stoma?

A stoma is a temporary opening created on the tummy, connected to the bowel, to allow waste to pass out into a bag while the bowel inside heals.

Who decides which surgery I get?

You'll be randomly assigned to one of the two surgery groups, like drawing lots, so neither you nor your doctor chooses the specific method for the study.

How long will I be followed up?

You'll have hospital check-ups at 6, 12, and 24 weeks after your first surgery, with a final visit 12 months later.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your medical care.

How to find out more

Valérie BRIDOUX, Pr

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Role of Protective Stoma After Primary Anastomosis for Gener…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.